Clinical trials to develop software medical devices are being conducted briskly. Particularly, the share of confirmatory clinical trials to win permission is increasing,

According to the Ministry of Food and Drug Safety, the number of approved clinical trial plans for software medical devices has steadily increased over the past five years, from six in 2018 to 49 in 2022.

Software medical devices are developed, manufactured, licensed, certified, and reported by software only. They are divided into three areas: diagnosis assistance and disease prediction, treatment, and mitigation of diseases and symptoms, digital treatment (assistance) devices, and surgical treatment and assistance.

By area, the total breaks down into 31 approvals for diagnosis assistance and prediction, including artificial intelligence-based software, 17 approvals for treatment and mitigation, including digital treatment (assistance) devices, and one surgical treatment and assistance, including augmented reality-based surgical assistance software.

In the digital treatment (assistance) device area, nine clinical trials to treat eight diseases won approval in 2012, but the number increased to 17 cases for 12 diseases.

While the development of products to alleviate insomnia or addiction symptoms had been the mainstream in digital treatment (assistance) devices, it was confirmed last year that they were being applied to more various diseases, such as ADHD (attention deficit hyperactivity disorder), mild cognitive impairment, and developmental impairment.

Of the 49 cases approved last year, 33 were confirmed clinical trials for approval, far outnumbering 16 exploratory clinical trials in the early stages of development.

Also, nine clinical trials were completed, 18 were ongoing, and 22 clinical trials had yet to be initiated, indicating that more time would be needed for these products to be used in the medical field.

In the diagnosis assistance and prediction area, various devices are being developed, including products for assisting in diagnosing the occurrence and location of acute cerebral infarction using brain CT images; assisting in detecting pancreatic cancer areas in ultrasound images; predicting the risk of myocardial infarction within a year by analyzing the medical records of patients with cardiovascular disease; and predicting the occurrence of acute cardiac arrest by analyzing blood pressure, heart rate, and respiration of inpatients.

For treatment and mitigation, products are being developed to improve attention deficit in pediatric patients diagnosed with ADHD based on games, improve and treat depression in patients with depression using virtual reality technology, and improve alcohol use disorders by inducing lifestyle changes.

“We will actively provide medical device-related information and improve regulations reasonably based on scientific regulator knowledge and expertise,” the ministry said. “The government will continue to provide useful information for businesses, including clinical trial situations, and communicate with them so that they can swiftly commercialize software medical devices, including digital treatment (assistance) devices as the core of digital healthcare.”